Metabolic Effects of the Exercise-metabolite Lac-Phe

NCT ID: NCT06743009

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2027-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this double-blinded, randomized cross-over clinical trial is to assess the isolated (i.e. outside the context of exercise) effects of Lac-Phe on appetite and glucose concentrations in healthy volunteers with obesity (BMI 28-35).

The main questions it aims to answer are:

* Does Lac-Phe reduce appetite in humans?
* Does Lac-Phe have glucose-lowering properties in humans?

During the study, participants will:

* receive an intravenous infusion of Lac-Phe on one study day and a NaCl infusion on another study day.
* drink a standard mixed meal
* eat an ad libitum meal test
* answer appetite questionnaires
* indirect calorimetry
* blood samples for hormone and substate analyses

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Overweight/Obese

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lac-Phe

Intravenous infusion of Lac-Phe

Group Type EXPERIMENTAL

N-lactoyl-phenylalanine

Intervention Type OTHER

Intravenous infusion of N-lactoyl-phenylalanine (Lac-Phe)

Control

Intravenous infusion of NaCl

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type OTHER

0.9% isotonic NaCl infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-lactoyl-phenylalanine

Intravenous infusion of N-lactoyl-phenylalanine (Lac-Phe)

Intervention Type OTHER

NaCl

0.9% isotonic NaCl infusion

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lac-Phe

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A body mass index (BMI) between 28-35 kg/m2
* Older than 18 years of age
* Hgb within a normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L)
* Females can be included if they are either postmenopausal or actively use hormonal contraception (e.g., oral contraceptive pill or hormone-releasing intrauterine device).

Exclusion Criteria

* Medications affecting glucose metabolism (e.g., Saxenda).
* Anemia
* Diabetes
* Ongoing cancer or other acute/chronic serious diseases (PI will determine)
* Inability to understand Danish or English
* Deemed unsuitable to participate by the PI and co-investigators.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SDCA research laboratory

Aarhus N, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mette GB Pedersen, MD, PhD

Role: CONTACT

0045+78450000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mette Pedersen, MD, PHD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-10-72-185-23

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Novel Alpha-Glucan Metabolism
NCT05058144 COMPLETED NA